Use of Drugs Not Approved by FDA Leads to $2.6 Million in Fines

Seven Ohio oncologists have pleaded guilty to causing the shipment of misbranded drugs based on their importation of cancer medications that were not approved by the Food and Drug Administration (FDA). Collectively, they will be required to pay nearly $2.6 million in fines, according to an announcement by the Stephen M. Dettelbach, United States Attorney for the Northern District of Ohio.

The physicians imported several drugs, including Zometa, Kytril, Taxotere, Gemzar, and Eloxatin. Lamont Pugh III, the HHS Inspector General’s Special Agent in Charge, noted, “The introduction of misbranded prescription medications and the subsequent billing of Medicare for such medication is improper and illegal.” A drug may be considered misbranded even if it is identical to a drug made by the same manufacturer that has been FDA-approved.